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4. Quality management system 4.1 General The manufacturer shall establish, document, imple...

2023-10-10T04:26:41

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3.18.2 Design validation means establishing by objective evidence that device specificatio...

2023-10-09T05:45:47

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1.4 If a manufacturer engages in only some operations subject to the requirements of this ...

2023-10-07T11:17:16

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1.3 The processes required by this Schedule, which are applicable to the medical device an...

2023-10-06T04:28:20

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7.5.1.1 General requirements The manufacturer shall plan and carry out production and serv...

2023-10-17T05:26:07

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(d) records needed to provide evidence that the realisation processes and resulting produc...

2023-10-13T05:12:37

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(d) records needed to provide evidence that the realisation processes and resulting produc...

2023-10-11T04:55:42

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4.2.4 Control of records: Records shall be established and maintained to provide evidence ...

2023-10-10T04:35:16

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4.2 Documentation requirements 4.2.1 General: The quality management system documentation ...

2023-10-10T04:28:46

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